Monitoring in Intensive Care Unit of Neuromuscular Blocking Agents Used for Acute Respiratory Distress Syndrome After Cardiothoracic Surgery

NCT02546947 | Completed DMC

• 1 other identifier: 2013-A00067-38
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

Brief Summary

Mortality in Acute Respiratory Distress Syndrome (ARDS) is high (40 to 60 %). Protective mechanical ventilation is the cornerstone of the ARDS therapeutic strategies. Recently, a prospective multicenter study demonstrates that short-term infusion of neuromuscular blocking agents (NMBA) reduces hospital mortality. However, the mechanisms through which NMBAs could improve survival remain speculative and the dose of NMBA needed to observe a beneficial effect is still debated. In hypoxemic ventilated patients, continuous cisatracurium infusion with an objective of no response at orbicularis oculi to train-of-four (TOF) stimulation and an objective of two responses had similar effects on respiratory parameters. In their study, Papazian and colleagues used cisatracurium with an initial standard dose of 15 mg followed by a continuous infusion of 37.5mg/h, based on previous results of studies with patients monitored for paralysis. Atracurium and its stereoisomer cisatracurium are non-depolarizing neuromuscular blocking drugs, both used in anaesthesia and intensive care units. The aim of this study was to compare in ARDS patients a dose adjustment of continuous-atracurium intravenous infusion with an end point of one or two response at orbicularis oculi to TOF stimulation, and a dose adjustment to achieve clinical goals of protective ventilation without monitoring of TOF stimulation.

Conditions

Acute Respiratory Distress Syndrome

Keywords

Respiratory Distress Syndrome, Adult; Neuromuscular Blocking Agents; Atracurium; Mechanical ventilation; ARDS; partial pressure of oxygen(PaO2) /inspired oxygen (FiO2) < 200; Positive End Expiratory Pressure (PEEP) > 5 since less than 48 hrs

Outcome Measures

Primary Outcomes (1)

• cumulative total dose of atracurium (mg per kg per hour, administered from the initial phase of ARDS until disruption ≥48 hours)

  was the primary outcome, calculated by the following formula:(Initial bolus dose +(standard bolus dose x number of repetition doses)+cumulative continuous infusion dose (mg/h x number of hours))/ weight (kg) x duration of administration (hour).

  2 years

Study Arms (2)

Appropriate clinical group

NO INTERVENTION

group of patients with clinical dose adjustment

TOF adapted group

ACTIVE COMPARATOR

group with an objective of less than 2 responses to TOF stimulation monitored

Other: Train of four monitoring

Interventions

Train of four monitoring OTHER

with an end point of one or two response at orbicularis oculi to TOF stimulation

TOF adapted group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ARDS with a PaO2 / FiO2 \< 200 with a PEEP \> 5 since less than 48 hrs
• Informed consent

You may not qualify if:

• NMBA allergy
• Age \< 18 yrs

Sponsors & Collaborators

• Centre Chirurgical Marie Lannelongue: lead

Study Sites (1)

Centre Chirurgical Marie Lannelongue

Le Plessis-Robinson, 92350, France

Location

Related Publications (1)

• Rezaiguia-Delclaux S, Laverdure F, Genty T, Imbert A, Pilorge C, Amaru P, Sarfati C, Stephan F. Neuromuscular Blockade Monitoring in Acute Respiratory Distress Syndrome: Randomized Controlled Trial of Clinical Assessment Alone or With Peripheral Nerve Stimulation. Anesth Analg. 2021 Apr 1;132(4):1051-1059. doi: 10.1213/ANE.0000000000005174.

  PMID: 33002927 DERIVED

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2015
• First Posted: September 11, 2015
• Study Start: June 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: February 27, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)